Device and method for spinal surgery

ABSTRACT

Instrumentation for fixing at least two spinal vertebrae by pedicle screw type bone anchoring implants and connecting elements via the posterior or posterolateral approach has at least one bone anchoring element designed to be fixed to a vertebra, pre-mounted with a disposable mounting tube and a sterile sealed packaging. A kit of instruments for inserting or removing a spinal implant, has at least two threaded bone anchoring elements, a rod-type or plate-type connecting element mechanically connecting the bone anchoring elements and locking elements for locking the connecting element in position in relation to the anchoring elements, in order to perform all of the surgical procedures relating to the insertion or removal of the implant, all of the required instruments are disposable and packed in a sterile manner in one or several sealed packagings.

CROSS REFERENCE TO RELATED APPLICATIONS

The instant application is a divisional application of U.S. patent Ser.No. 13/518,949, filed Jun. 25, 2012, entitled DEVICE AND METHOD FORSPINAL SURGERY (Our Ref: 12-228).

BACKGROUND

The invention relates to a device allowing performance of spinalstabilisation by a screw-type bone anchoring element via the posterioror posterolateral approaches.

The device according to the invention is designed particularly, but notexclusively, for lumbar, thoracic or furthermore posterior cervicalspinal osteosynthesis via minimally invasive or open surgicalapproaches.

In the conventional method in itself, in case of anatomical dysfunctionsof the vertebral column, pedicle screw-type bone anchoring elements areinserted (installed) in the vertebrae, interconnected by rod-type orplate-type connecting elements.

The state of the art in the field of vertebral column surgery involvesproviding hospitals with implants and sets of instruments for theirinsertion (installation). Some companies specialised in the field supplyready-to-use, sterile packed implants. The sets of instruments reusableafter decontamination and sterilisation present many disadvantages. Therisk of interpatient contamination is very high; cleaning,decontamination and sterilisation are steps which are sometimes almostimpossible to perform correctly in view of complex designs with manycavities inside the instruments. These steps are a financial burden forthe hospitals and represent very high costs, both in human and materialterms.

Loss, breakage, wear and damage of an instrument may result indisastrous consequences for the patient or even cause cancellation ofthe surgery. The logistics also present many disadvantages; cumbersomeand costly both for the industrialist and the hospital, they most ofteninvolve significant inventories. Indeed, since surgeons only operate twodays a week in the majority of cases, the number of sets of instrumentsmade available to the hospital depends on the activity, withtraumatology operations being added if necessary to the surgicalprogramme.

The rotations of sets between the hospital and the industrialist'slogistics service are therefore very large in number, whichsignificantly increases the risks of losses and errors.

In other surgical fields, in order to take account of the safety aspectboth for the patient and surgeon, the financial, human and materialaspect for the hospital in addition to the service offered and expectedby the industrialist's customers, it has been proposed to shift towardsdisposable “all sterile” surgery. International application WO 98/22035is known for example. The latter describes a kit of surgicalinstruments, manufactured economically from synthetic sterile material.This type of kit is marketed for genecological or microsurgicaloperations. These generic instruments of the scissor, dissection plieror furthermore scalpel type are not intended for insertion of anorthopaedic implant and are not caused to undergo high mechanicalstresses. Transformation of a metallic instrument to disposable polymeris known in many medical fields.

International application WO 2005/016183 is also known. It describes animplant kit of the vertebral plate and screw type combined withdisposable sterile packed instruments. Apart from the disadvantage ofonly offering a single screw length and diameter for the bone anchoring,this method only describes a single type of instrument: a screwdrivershank and its handle. This international application does not offer anytechnical solution for designing and manufacturing instruments subjectto major stresses such as the vertebral distractor which is absolutelyessential for inserting the implant.

SUMMARY OF THE INVENTION

The present invention intends to solve in their entirety the problemsassociated with use of polymer materials for manufacturing sterilepacked disposable surgical instruments and more specifically of thepedicle screw type for spinal surgery.

To this end and according to a first aspect, the invention proposes apre-mounted pedicle screw-type bone anchoring element with amultifunctional mounting tube, all prepared at the factory in disposablesterile sealed packaging. More specifically, it refers to a spinaldevice for fixing vertebrae via the posterior or posterolateralapproach, characterised in that said device comprises at least:

a bone anchoring element of the pedicle or vertebral screw type,comprising a proximal portion equipped with an interface for attaching arod-type or plate-type connecting element and a threaded distal portion,

a mounting tube interdependently pre-mounted on the bone anchoringelement, said tube being removable from the bone anchoring element,

a sterile sealed packaging of the bone anchoring element and thepre-mounted mounting tube.

According to one embodiment, the mounting tube comprises a longitudinalopening, emerging in the proximal portion of the bone anchoring elementfor passage of the connecting element.

Advantageously, the pre-mounted tubes are removable after implantationof the bone anchoring element and its locking element.

According to one embodiment, the internal diameter of the mounting tubeallows passage of a locking element for locking the connecting elementon the bone anchoring element.

According to one embodiment, the internal diameter of the mounting tubeallows passage of accessories for positioning a locking element.

Advantageously, the device comprises an accessory passing through themounting tube and having one end pre-mounted on the bone anchoringelement.

Advantageously, the mounting tube is equipped with means of retainingthe accessory in alignment with the bone anchoring element. According toa specific configuration, the means of retention comprise lugs arrangedon the internal face of the mounting tube. Provision may be made, inaddition to or in exchange for the lugs, for a retaining fin installedon the distal end of the mounting tube in order to retain the accessoryin a given position in relation to the mounting tube and the boneanchoring element.

According to a particular variant, the mounting tube is provided with atleast one dovetail in its internal passage which is complementary withthe accessory for positioning of the locking element in order to obtaina sufficiently resistant interconnection with regard to the stressesexerted on this assembly.

According to one embodiment, the mounting tube is made of composite,polymer, ferrous or non-ferrous alloy material or furthermore acombination of these different materials.

According to one embodiment, the mounting tube is overmoulded on thebone anchoring element.

According to one embodiment, the mounting tube is made of one or severalmaterials, with at least one of said materials being incompatible withan autoclave sterilisation cycle involving a holding phase at 134° C.for 18 minutes.

According to one embodiment, the distal end of the mounting tubecomprises an indentation for positioning a handle-type perpendicularretaining element. This perpendicular retaining element is mainly usedduring tightening of the locking element with a counter-torque effect,thereby avoiding rotation of the assembly of the bone anchoring elementand the mounting tube.

According to one embodiment, the distal end of the mounting tubecomprises a threaded or tapped area. This thread or tap is designed toreceive a pushing element of the locking element holding tube describedbelow.

According to one embodiment, the mounting tube consists of twohalf-shells.

According to one embodiment, the two half-shells are identical.

According to one embodiment, the distal portions of the two half-shellsare contiguous.

According to one embodiment, the continuous portions of the twohalf-shells comprise a mortise and tenon positioning means, or similarlocating means in order to ensure proper positioning of these twohalf-shells.

According to one embodiment, the two half-shells are adhesively bonded,welded or clipped.

According to a particular variant, the proximal connection of thehalf-shell on the bone anchoring element is provided by an indentationcomplementary with the shape of this half-shell such that assembly ordisassembly is performed by rotating the half-shell around the boneanchoring element.

According to this particular variant, once the distal portions of thetwo half-shells have been interconnected, it is impossible to separatethe latter from the bone anchoring element, while allowing easydisassembly when the two half-shells are disconnected.

According to one embodiment, the two half-shells are interdependentlyretained, preferably by means of a ring on the distal end of saidhalf-shells.

Advantageously and according to this particular variant, the distalportion of this ring is equipped with a thread and a indentation. Thisthread is designed to receive a pushing element of the locking elementholding tube and the indentation is designed to receive a perpendicularretaining element.

According to one embodiment, the ring comprises at least onebayonet-type shape which interconnects with studs arranged on the twohalf-shells, thereby allowing easy and rapid assembly of said ring.

According to one embodiment, a compression spring is located between thering and the two half-shells in order to guarantee a secure fit of theassembly.

According to one embodiment, the ring comprises at least one transversespindle between the ring and the two half-shells.

According to one embodiment, the dimensioning of the spindle is definedsuch as to break under a shear load according to a given torque.

Advantageously, the mounting tube and the ring are arranged to form arigid assembly.

Advantageously, the two half-shells are arranged to form a guide tubewhen retained interdependently with each other.

Advantageously, the two half-shells each have a proximal end arranged tolock into engagement with the bone anchoring element.

Advantageously and according to this particular variant, this breakagetorque is identical to the tightening torque of the locking elementwhich secures the rod connecting element in the bone anchoring element.

Advantageously and according to this particular variant, this breakagedetermines disassembly of the ring and therefore also of the twohalf-shells.

According to one embodiment, the locking element is interdependentlypre-mounted with a locking element holding tube in order to form alocking assembly, with the locking element being removable from thelocking element holding tube.

Advantageously, this retention is performed by a tap.

According to a particular variant, this tap may be slightly differentfrom the thread of the locking element in order to ensure its retentionby trapping.

According to a particular variant, the locking element is retained by aclipping.

Advantageously, the locking assembly can be sterile packed.

According to one embodiment, the locking assembly is sterile packed inthe sealed packaging.

According to one embodiment, the locking element holding tube is ofdimensions that allow its insertion into the mounting tube. The mountingtube may advantageously have a tubular internal wall provided with atleast one locating relief, with the locking element holding tube havinga complementary locating relief of a shape complementary with thelocating relief of the mounting tube. The locking element holding tubemay furthermore have a proximal portion provided with a bearing relief,located opposite the interdependence interface of the bone anchoringelement when the locking element holding tube is inserted into themounting tube, in order to rest a connecting element on theinterdependence interface of the bone anchoring element. The device mayfurthermore comprise a pushing element interacting with the lockingelement holding tube for insertion of the locking element holding tubeinto the mounting tube.

Advantageously, the proximal end is equipped with two lugs on eitherside of the locking element, of a length at least equal to the height ofthe locking element in relation to the latter's face intended to comeinto contact with the rod. The width of these lugs cannot be greaterthan the diameter of the rod connecting element. The function of thesetwo lugs is to allow bearing on the rod connecting element without anycontact of the locking element either with the bone anchoring element orwith the rod connecting element.

According to a particular variant, the external shape of the lockingelement holding tube is provided with two dovetails of a shapecomplementary with the two half-shells.

These complementary dovetails between the two half-shells and thelocking element holding tube considerably reinforce the assembly,thereby avoiding any risk of separation of the two half-shells underhigh stresses and imparts greater mechanical resistance in flexion andtorsion.

According to a particular variant, the total length of the lockingelement holding tube is greater than that of the two half-shells orfurthermore of the two half-shells and of the ring.

According to this particular variant, the distal portion of the lockingelement holding tube and the internal shape of the pushing element arecompatible with positioning the rod connecting element at the bottom ofthe U-shaped housing provided of the bone anchoring element. The lockingelement holding tube therefore also serves as a rod pusher.

According to one embodiment, the pushing element comprises a thread or atap which interacts with the threaded or tapped area of the mountingtube for positioning of the connecting element.

Advantageously, the mounting tube, when the locking element holding tubeis positioned inside it, forms a guide tube.

Advantageously, the mounting tube and the locking element holding tube,when it is positioned inside it, form a rigid assembly.

According to one embodiment, the locking element holding tube has aninternal shape allowing passage of a screwdriver for tightening oruntightening the locking element.

According to one embodiment, the locking element holding tube is made ofcomposite, polymer, ferrous or non-ferrous alloy material or furthermorea combination of these different materials.

According to one embodiment, all the components of the device aredisposable.

According to one embodiment, all the components of the device are packedin a sterile manner in one or several sealed packagings.

In the above, emphasis has been placed on the existence of a sterilepackaging for the bone anchoring element and the pre-mounted mountingtube.

According to another aspect of the invention however, the latter alsocovers the mechanical characteristics of the tube and its fixing to thebone anchoring element, regardless of their sterile packaging. Hence,the invention also refers to a spinal device for fixing vertebrae viathe posterior or posterolateral approach, comprising an anchoringelement and a tube and distinguished by one or several of thecharacteristics described in paragraphs [0011] to [0051], consideredindividually or in combination.

According to another aspect of the invention, the latter refers to a kitof instruments for inserting or removing a spinal implant, comprising atleast two threaded bone anchoring elements, a rod-type or plate-typeconnecting element mechanically connecting the bone anchoring elementsand locking elements for locking the connecting element in position inrelation to the anchoring elements, in order to perform all of thesurgical procedures relating to the insertion or removal of saidimplant, characterised in that all of said required instruments aredisposable and packed in a sterile manner in one or several sealedpackagings.

According to a particular variant, the kit of instruments is reduced forinsertion or removal of the implants. It mainly consists of twoscrewdriver shanks (bone anchoring element and locking element), twomultifunctional handles, rod holding plier and compression-distractionplier, i.e. a total of six elements.

Advantageously, the instrumentation kit for insertion or removal of theimplants only consists of six instruments owing to their multifunctionaldesigns and the mounting tubes and locking element holding element partspre-mounted on said implants.

Advantageously and according to a particular variant, the inventionproposes control of the tightening torque of the locking element inorder to secure retention of the rod connecting element on the pediclescrew-type bone anchoring elements.

Advantageously, the invention offers the surgeon a choice of surgicalapproach, by a minimally invasive approach or by conventional opensurgery.

According to one embodiment, the instruments are made of composite,polymer, ferrous or non-ferrous alloy material or furthermore acombination of these different materials.

According to one embodiment, the disposal instrument device comprises atleast one screwdriver shank, a handle and a pair of plier.

According to one embodiment, the kit comprises a “T”-shaped handleequipped with a torque limiter for final torque tightening of thelocking element. The tightening torque of the locking element is optimumin order to guarantee retention of the rod connecting element in thebone anchoring element.

Advantageously, the pushing element of the locking element holdingtube/rod introducer is also the T-shaped handle which is equipped with athread corresponding to that of the distal end of the two half-shells orof the ring.

Advantageously, this T-shaped handle is designed to receive twoscrewdriver shanks for the bone anchoring element and the lockingelement.

Advantageously, this T-shaped handle is cannulated over its entirelength allowing passage of the screwdriver shanks.

According to this particular configuration, the proximal meshingportions of the pedicle screw and stopper screwdriver shanks aredifferent.

According to this particular configuration, the torque function of thisT-shaped handle is only applicable to the shank of the screwdriver fortightening the locking element.

According to one embodiment, the kit comprises a straight handleallowing positioning or disassembly of the bone anchoring elements,temporary tightening or untightening of the locking elements andperpendicular retention of the device.

Advantageously, this straight handle is designed to receive thedifferent screwdriver shanks (pedicle screw and stopper).

Advantageously, this straight handle is cannulated over its entirelength allowing passage of the different screwdriver shanks.

Advantageously, provision can also be made for the straight handle alsoallowing use as a T for positioning or disassembly of the bone anchoringelements and tightening or untightening of the locking elements, suchthat a greater torque is easier to apply.

Advantageously, the perpendicular retaining element is also the straighthandle. One of the ends of the latter is provided with a indentationcomplementary with that of the distal end of the two half-shells or thering.

According to one embodiment, the straight handle may be arranged toallow retention of the bone anchoring element for tightening oruntightening the locking elements. One of the ends of this straighthandle is provided with a shape complementary with the head of the boneanchoring element.

Advantageously, this straight handle therefore allows, during tighteningor untightening of the locking element, exertion of an counter-torqueeffect both when the two half-shells or half-shells+ring are in positionand when the latter are disassembled.

According to one embodiment, the straight handle may also allow grippingthe locking element and guiding the latter on the bone anchoringelement. This grip is arranged in order to securely retain the lockingelement in its end near the shape complementary with the head of thebone anchoring implant.

Advantageously, this retention is performed by a tap.

According to a particular variant, this tap may be slightly differentfrom the thread of the locking element in order to ensure its retentionby trapping.

According to a particular variant, the locking element is retained by aclipping.

Advantageously, the kit of instruments comprises plier for compressionand plier for distraction of the bone anchoring elements, with thecompression plier and distraction plier only forming a single pair ofpliers.

According to one embodiment, the manoeuvring plier comprise two armsallowing compression and distraction of the bone anchoring elements.This two-armed manoeuvring plier may comprise curved proximal ends withnotching on the convex portions.

Advantageously, this two-armed manoeuvring plier comprises curvedproximal ends with longitudinal positive location (indexation). Thepositive location can be performed by a groove on one of the arms and aprotruding stud on the other arm.

Advantageously, the kit of instruments may include a plier (900)comprising two crossed arms symmetrical in relation to a reference planeand fixed to each other by means of a joint, wherein each arm has afork-shaped end to overlap a rod, said fork-shaped ends of each armbeing arranged facing each other in relation to the plane of symmetry,wherein the ends of the arms form compression ends and wherein the endsopposite the compression ends of each arm are arranged to allow grippingof the rod during a movement in which the compression ends are movedtowards each other.

The kit of instruments may also include a plier comprising two crossedarms symmetrical in relation to a reference plane and joined to eachother by means of a joint, wherein each arm has first and secondfork-shaped ends to overlap a rod, wherein one of the ends of one of thearms is arranged with the end of the other arm positioned opposite theformer arm in relation to the plane of symmetry in order to formdistraction ends and wherein the other ends form compression ends.

According to another aspect of the invention, the latter refers to anoperation of inserting or removing a spinal implant, comprising at leasttwo threaded bone anchoring elements, a rod-type or plate-typeconnecting element mechanically connecting the bone anchoring elementsand locking elements for locking the connecting element in position inrelation to the anchoring elements, characterised in that theinstruments interacting with the bone anchoring elements and the lockingelements during insertion or removal of the implant are taken from oneor several sealed sterile packagings at the beginning of the operationand are discarded at the end of the operation without being sterilisedagain.

BRIEF DESCRIPTION OF THE DRAWINGS

Other aims and advantages of the invention will appear in the course ofthe following description, made with reference to the appended drawingsin which:

FIG. 1 represents a diagrammatic view of a device according to a firstembodiment of the invention;

FIG. 2 represents a diagrammatic view of the kit of instrumentsaccording to a first example of embodiment;

FIGS. 3 a and 3 b represent the connection between the bone anchoringelement and the multifunctional mounting tube; FIG. 3 c represents adetail of the connection between the bone anchoring element and themultifunctional mounting tube illustrated in FIG. 3 a;

FIG. 3 d represents a detail of a connection between the bone anchoringelement and the multifunctional mounting tube according to an embodimentvariant;

FIGS. 4 a and 4 b represent different assemblies of the ring on the twohalf-shells forming the multifunctional mounting tube;

FIG. 5 represents a specific assembly of the two half-shells forming themultifunctional mounting tube;

FIG. 6 represents the locking element holding tube;

FIG. 7 represents the locking element holding tube inserted into the twohalf-shells forming the multifunctional mounting tube;

FIG. 8 represents a cross-section of the multifunctional T-shaped handlein its torque version;

FIG. 9 represents a cross-section of the multifunctional straighthandle;

FIGS. 10 a to 10 g represent the differing operating steps forpositioning the bone anchoring element, the rod connecting element andthe locking element;

FIG. 11 represents a specific function of the handles during tighteningor untightening the locking element when the mounting tube is no longerpositioned on the implant;

FIG. 12 represents a diagrammatic view of the plier forcompression/distraction of the bone anchoring elements in thecompression version;

FIG. 13 represents a diagrammatic view of the plier forcompression/distraction of the bone anchoring elements in thedistraction version;

FIG. 14 represents a specific means of joint of this plier in thedistraction version;

FIG. 15 represents a diagrammatic view of a device according to a secondembodiment of the invention;

FIG. 16 represents a diagrammatic view of a kit of instruments accordingto a second example of embodiment of the invention;

FIG. 17 represents a diagrammatic view of the mounting tube and the ringforming the device in FIG. 15, said ring being illustrated unassembledon the mounting tube;

FIG. 18 represents a bottom view of the ring in FIG. 17;

FIG. 19 represents a cross-sectional view along the axis XIX-XIX of themounting tube in FIG. 17;

FIG. 20 represents a cross-sectional view along the axis XX-XX of thetube/screwdriver assembly in FIG. 15 on which the bone anchoring elementis pre-mounted;

FIGS. 21 a and 21 b respectively represent a detailed view of theproximal end and of the distal end of the tube illustrated in FIG. 20.

FIG. 22 represents a diagrammatic view of a tube/screwdriver/handleassembly according to a variant of use;

FIGS. 23 a and 23 b represent a compression plier contained in the kitof instruments in FIG. 16, said compression plier being illustratedaccording to two situations of use;

FIGS. 24 a and 24 b represent a distraction plier contained in the kitof instruments in FIG. 16, said distraction plier being illustratedaccording to two situations of use; and

FIGS. 25 a to 25 c represent the steps for positioning the lockingelement when the mounting tube has been disassembled.

For greater clarity, identical or similar elements of the differentembodiments are marked by identical reference signs on all the figures.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

With reference to FIG. 1, a device (1) designed to be fixed on to avertebra is described, comprising a means of bone anchoring (2) and itsmeans of closure (3), respectively interdependently pre-mounted on tubes(7) and (8), all prepared at the factory in disposable sterile sealedpackaging.

In order to facilitate reading of that which follows, the device 1described above will subsequently be referred to as “screw device (1)”.

In a specific configuration not illustrated, the screw device (1) maycomprise several means of bone anchoring (2) and several means ofclosure (3) interdependently pre-mounted on disposable tubes (7) and(8), all in a same disposable sterile sealed packaging.

The means of bone anchoring (2) consists of a threaded portion (4)designed to be inserted into the bone and a head portion (5) intended toreceive a rod-type or plate-type connecting element (6).

In order to facilitate reading of that which follows, the bone anchoringelement (2) will subsequently be known as “screw (2)”, the head portion(5) will be subsequently known as “head of the screw (5)”, the rod-typeor plate-type connecting element (6) will subsequently be known as “rod(6)” and the locking element (3) will subsequently be known as “stopper(3)”. The screw (2), rod (6) and stopper (3) assembly will subsequentlybe known as the “implant”.

In a specific configuration, the head of the screw (5) is arranged witha U shape (25) provided with a channel designed to receive the rod (6).Advantageously, the channel is bordered by two branches provided with aninternal tap (26) designed to receive the stopper (3) in order to attachthe screw (2) and the rod (6). The threaded portion (4) of the screw (5)may be fixed or mobile in relation to the head of the screw (5); thistype of screw (5) with a stopper (3) forms part of the public domain andconstitutes one of the states-of-the-art of spinal surgery for fixingvertebrae.

The most frequently used material for manufacturing implants istitanium. In a specific configuration of the invention, the materialused for manufacture may be any implantable material known or unknown todate, such as Peek, stainless steel, cobalt chrome or furthermore acomposite based on fibreglass or carbon. Coatings of the HATCP type(HydroxyApatite TriCalcium Phosphate) or others may also be applied inorder to improve bone anchoring or the overall mechanical resistance ofthe implant.

The disposable tubes (7) and (8) may be manufactured from any materialknown or unknown to date, such as composites, polymers and ferrous andnon-ferrous metals (aluminium) as long as they fulfil thebiocompatibility criteria related to the application. Preferably, thematerial used will be recyclable in order to comply with environmentalprotection requirements. Coatings may also be applied in order to fulfilthe biocompatibility criteria or furthermore enhance the mechanicalcharacteristics.

Preferably at least one of said materials forming the device (1) isincompatible with an autoclave sterilisation cycle involving a holdingphase at 134° C. for 18 minutes.

The chosen sterilisation method will be compatible depending on thecharacteristics of said materials according to the state of the art.This sterilisation will be preferably performed by gamma irradiation orfurthermore according to a specific process using ethylene oxide (ETO).

FIG. 2 also describes a kit of instruments (10) for disposable use,sterile packed for inserting or removing implants. Totalling sixinstruments in this particular configuration, they make it possible toperform all of the surgical procedures required for inserting orremoving implants. Advantageously, the materials or coatings used formanufacturing this kit of instruments (10) are the same as those whichmay be used for manufacturing the tubes (7) and (8).

This device of a kit of instruments (10) offers many advantages such asthat of reducing the overall cost of spinal surgery and guaranteeing nointerpatient contamination, thereby significantly reducing the number ofnosocomial infections.

This device of the kit of instruments (10) is mainly composed ofscrewdriver shanks, handles and pliers.

Advantageously, non-limitatively and non-restrictively, the kit ofinstruments (10) makes it possible to perform the following surgicalprocedures: insertion of the screws (2) in the pedicles of thevertebrae, arching of the rod (6) in order to conform to the patient'sanatomy, insertion of the rod (6) regardless of the introduction forces,positioning of the stopper (3), correction manoeuvres of theinstrumented vertebrae of the compression and distraction type andcontrolled and secure final tightening of the stopper (3).

Advantageously and according to a particular configuration, the kit ofinstruments (10) includes trial rods allowing the surgeon to determinethe optimum length and curvature before the choice of rods (6) to beimplanted.

Advantageously, the same kit of instruments (10) may be used forremoving the equipment after osteosynthesis, or for any other clinicalreasons.

Advantageously, many instruments making up this kit (10) aremultifunctional. All the characteristics will be subsequently describedin detail.

Advantageously, the tubes (7) and (8) respectively pre-mounted on thescrew (2) and the stopper (3) are also multifunctional.

Advantageously, the combination of the kit of instruments (10) andpre-mounted tubes (7) and (8) offers the surgeon a choice of surgicalapproach, either by a median, lateral or bilateral minimally invasiveapproach or by conventional open surgery.

FIGS. 3 a and 3 b describe in the preferred embodiment the fixing of themounting tube (7) on the screw (2).

The external surface of the head of the screw (5) comprises twoindentations (20) arranged on either side of the U-shaped channel (25).The indentation is made up of a channel (27) and an internal housing(21). In this configuration, the mounting tube (7) consists of twohalf-shells (30, 31). The female shape of the indentation on the head ofthe screw (5) is reproduced in male form on the proximal ends of thehalf-shells (30 and 31). Advantageously, the male external shape of thehead of the screw (5) is reproduced in female internal form (22) on theproximal end of the two half-shells in order to strengthen andconsolidate the two half-shells (30 and 31) and the screw (2) in alldirections (except that of rotation with the internal indentation (21)as the centre of rotation).

More particularly, the proximal end of each half-shell has a cavity witha shape complementary to the shape of one of the branches of the head ofthe screw (5). Hence, when the two half-shells (30, 31) are installed onthe head of the screw (5), the branches of the latter are trapped in thecavities arranged on each of the proximal ends of the half-shells, withthe wall bordering each cavity appreciably “hugging” the externalsurface of the branches of the head of the screw (5). Advantageously,the cavity of each proximal end comprises a lug arranged such that whenthe proximal ends are placed on the head of the screw (5), the lugengages in the indentation arranged on the head of the screw. In theembodiment illustrated, the recesses are arranged on the upper end ofthe head of the screw (5).

It is of course obvious that the invention is not limited with regard tothe means of retention of the implant to the mounting tube and the lugsas illustrated in FIGS. 4 to 6, with the possibility of making provisionfor all other forms of lugs or all other means of retention of theimplant without departing from the framework of the invention.

Advantageously, the internal housing (21) is arranged to allowpositioning of the half-shell by pivoting/rotating the latter on thehead of the screw (5) according to direction (A) with the internalhousing (21) as the rotation point. This form of male/female indentationwith an internal housing (21) offers the advantage of beingnon-removable when the distal portions of the two half-shells arecontiguous (FIG. 4 a) and allows easy disassembly when these twohalf-shells (30 and 31) are no longer contiguous (FIG. 5).

FIGS. 3 c and 3 d respectively illustrate two examples of shape ofindentations. In the two examples illustrated, the channel (27) formstogether with the housing (21) a receiving cavity having an internalheight L2 greater than the height L1 of the entrance opening (27 a).This dimensional difference allows locking of the proximal end of themounting tube (7) on the head of the screw (5), at least in translationalong the axes (x, y).

In the embodiment illustrated, the dimensional difference is borne onthe bottom of the indentation under the entrance opening (27 a) in orderto allow disassembly of the half-shells (7) by pivoting the latter onthe lower bearing edge (21 a) bordering the entrance opening (27 a).

In one particular configuration, the mounting tube (7) is overmoulded onthe screw.

Advantageously, the mounting tube (7) is provided with an aperture (32)in the continuation of the U-shape (25) of the head of the screw (5) inorder to allow passage and introduction of the rod (6) (FIGS. 10 b and10 c).

Advantageously, the distal portion of the tube (7) is equipped with athread (35) and a indentation (36). This This thread (35) is designed toreceive a pushing element (60) of the locking element holding tube (8)and the indentation (36) is designed to receive a perpendicularretaining element (70) (FIG. 10 g). The thread (35) is arranged on thesurface opposite to the surface on which the indentation is arranged. Inthe embodiment described, the thread is arranged on the internal surfaceof distal portion of the tube (7) and the indentation (36) on theexternal surface of said tube.

The mounting tube (7) is not illustrated in its “one-piece” version, butonly in the two preferred embodiments as described below. The externalshape of the tube may be of any shape, such as oval or furthermorehexagonal regardless of the version.

Fixing of the tube (7) on the bone anchoring implant (2) may be effectedby various designs which are not illustrated. The tube (7) may be madeup of 2 arms forming a plier, a fork with its closure system forretention on the implant, or furthermore non-restrictively, of a solidtube and its means of fixing to the implant, wherein the means ofconnection (21) of the implant are consistent with the design of thetube (7).

FIG. 5 describes a preferred embodiment for the junction between the twohalf-shells. In this configuration, the two half-shells (30 and 31) areidentical and are interconnected by a tenon (33)/mortise (34) device.

In a particular configuration, these two half-shells may be adhesivelybonded, soldered, clipped or interlocked, but the preferred embodimenthowever involves a junction by means of an additional ring (40) (FIGS. 4a and 4 b).

In this case, it is the ring that receives the thread (35) and theindentation (36) provided at the distal end of the mounting tube (7).Advantageously, the internal shape of the ring corresponds to theexternal shape of the mounting tube (7) made up of the two half-shellsin this case.

Advantageously, in a first preferred embodiment, the ring is providedwith at least one bayonet (41) in the thickness of the ring (40). Inorder to attach the ring on the mounting tube (7), the latter comprisesat least one stud (42) opposite the bayonet(s). In order to maintain thering (40) in place on the mounting tube (7), a compression spring notillustrated is interposed between the two elements. Assembly anddisassembly of the ring and the two half-shells are thereby simplified.

In a second preferred embodiment, the ring (40) is fixed by at least onepenetrating stud (43). During the tightening forces of the stopper (3),this stud is subjected to the shearing forces between the torquerequired for tightening the stopper (3) and the counter-torque exertedby the perpendicular retaining element (70) via the indentation (36).Advantageously, the penetrating stud (43) is dimensioned in order tobreak under the shearing force. Advantageously, the breaking torquedepends on the optimum tightening torque of the stopper (3).Advantageously, the ring (40) is separated from the tube (7) when thefinal tightening of the implant is performed and disassembly of the twohalf-shells is thus simplified.

FIGS. 6 and 7 show the locking element holding tube (8) pre-mounted onthe stopper (3), in addition to its interconnection in the mounting tube(7) of the screw (2).

The locking element holding tube (8) is arranged in order to securelyretain the proximal portion of the stopper (3). The locking elementholding tube (8) and stopper (3) unit forms the locking assembly.

Advantageously, the stopper (3) is retained by a tap arranged in thelocking element holding tube (8).

According to a preferred variant, this tap is slightly different fromthe thread of the stopper (3) in order to ensure its retention bytrapping.

According to a particular variant, the stopper (3) is retained by aclipping.

Advantageously, the distal end of the locking assembly is equipped withtwo lugs (50) on either side of the stopper (3), of a length at leastequal to the height of the stopper in relation to the latter's faceintended to come into contact with the rod (6). The width of these lugs(50) cannot be greater than the diameter of the rod (6). The function ofthese two lugs is to allow bearing on the rod (6) without any contact ofthe stopper (3) either on the head of the screw (5) or on the rod (6)until contact of said rod with the interdependence element of the screw(5), i.e. the bottom of the U-shaped channel (25).

According to a preferred configuration, the external shape of thelocking element holding tube (8) is provided with at least one dovetail(51) with a shape complementary to the internal shape of the mountingtube (7) of the screw (2). Advantageously, the locking element holdingtube (8) is provided with two dovetails (51), one on each half-shell.

These complementary dovetails (51) between the two half-shells (30 and31) and the locking element holding tube (8) mechanically reinforce theassembly, thereby avoiding any risk of separation or disconnection ofthe two half-shells under high stresses and impart resistance in flexionand torsion to the assembly.

According to a preferred particular configuration, the total length ofthe locking element holding tube (8) is greater than that of themounting tube (7), or furthermore of the two half-shells+ring. It istherefore possible to remove the locking element holding tube (8) oncethe stopper (3) has been positioned.

According to this particular configuration, the distal portion (52) ofthe locking element holding tube (8) and the internal shape (62) of thepushing element (60) are compatible for positioning the rod (6) at thebottom of the U-shaped housing (25), the interdependence element of thescrew (2). Advantageously, this form (52) is cylindrical.

Advantageously, pushing of the tube (8) by the pushing element (60) maybe performed at the end (53) of said tube, or on the shoulder (54)formed by the arrangement of the shape (52).

Advantageously, the internal diameter of the locking element holdingtube (8) is designed for passage of the screwdriver.

In the embodiment described, the locking element holding tube (8)therefore also serves as a rod pusher.

Advantageously, the pushing element (60) of the locking element holdingtube (8)/rod introducer is the T-shaped handle (60) which is equippedwith a thread (61) corresponding to that of the distal end of themounting tube (7) of the screw (2) as shown in FIGS. 8, 10 and 11.

Advantageously, this T-shaped handle is cannulated (63) over its entirelength allowing passage of the screwdriver shank of the stopper (80′).

According to a particular configuration, this handle (60) isdynamometrically adjusted to the optimum tightening torque of thestopper (3) blocking the rod connecting element (6). Familiar to theperson skilled in the art, the torque mechanism is formed of two toothedrings (64) and (65) and a series of “Belleville” washers (66) or aspring.

According to this particular configuration, the proximal meshingportions of the different screwdriver shanks (80 and 80′) are differentin order to solely allow the torque function on the screwdriver shankintended for tightening the stopper.

According to another particular configuration not illustrated, thescrewdriver shank (80′) for tightening the stopper (3) has a breakinitiation in order to break under the tightening force. Advantageously,the breaking torque depends on the optimum tightening torque of thestopper (3). In this particular configuration, the screwdriver shank(80′) may be formed in 2 sections longitudinally interconnected; anendpiece with the breakage initiation and the actual screwdriver shank.The endpiece in this case forms an integral part of the locking assembly(8 and 3).

FIG. 9 shows the perpendicular retaining element (70) of the tube (7).One of the ends of this perpendicular retaining element (70) is providedwith a indentation (71) complementary with that of the distal end of themounting tube (7) of the screw (2). In the preferred configuration, theindentation (71) is formed by notches (72). According to differentparticular embodiments, this indentation (71) may adopt the shape of ahexagon, a polygon or furthermore a hexalobe mentioned by way ofexample, with the intended purpose being maintenance in rotation of theperpendicular retaining element (70) on the tube (7).

Advantageously, this perpendicular retaining element (70) alsoconstitutes a straight handle and is capable of receiving the differentscrewdriver shanks (80 and 80′). a indentation (73) is arrangedaccordingly.

It may be advantageous to also provide a means of retention of thescrewdriver shanks (80 and 80′) in this handle (70). In the preferredconfiguration, this retention is performed by an O-ring (74) of a shapeand size compatible with the diameters of the screwdriver shanks (80 and80′). This retention may also be performed by any elastic shape, such asa tongue for example (not illustrated).

Advantageously, a complementary indentation (76) is arranged on the sideof the handle, when the latter is considered in its straight position(one will subsequently refer to the straight handle) in order for thelatter to be used as a T-shaped handle compatible with the screwdrivershanks (80 and 80′).

According to a preferred configuration, one of the ends of this straighthandle (70) is provided with a complementary shape (75) to the externalshape of the head of the screw (5).

This straight handle therefore allows, during tightening or untighteningof stopper, exertion of a counter-torque effect both when the mountingtube (7) is in position and when the latter is disassembled.

Advantageously, this straight handle is cannulated over its entirelength allowing passage of the screwdriver shank of the stopper (80′).

According to a particular configuration, the handle is arranged in orderto securely retain the tightening stopper (3) in its end near thecomplementary shape (75) to the head of the screw (5). This possibilityallows positioning of the stopper (3) in the screw (2) if the mountingtube (7) is not in position.

Advantageously, this retention is performed by a tap (76) of identicalshape to the stopper (6), or slightly different in order to ensureretention of said stopper (6) by trapping.

According to another particular variant, the stopper is retained by aclipping.

FIGS. 10 a to 10 g and 11 describe the different surgical steps of theinvention (the vertebrae are not illustrated for reasons of simplicity):

-   -   FIG. 10 a represents positioning of the screw device (1) in the        vertebrae. The handle (70) and the screwdriver shank (80) are        used for screwing. A complementary ring not illustrated may be        used for attaching all these elements, by means of the thread        (35) of the screw device (1).    -   FIG. 10 b represents two screw devices (1) with positioning of        the rod (6) in distal portions of the mounting tubes (7) which        are advantageously located outside the patient's wound beyond        the skin represented hereby the line (P).    -   FIG. 10 c represents insertion of the rod (6) through the two        mounting tubes (7). This downwards manoeuvre of the rod may be        performed either using the locking element holding tubes (8) or        by means of scissors-type or another type of rod holding plier.        In this second configuration, the scissors-type rod holding        plier not illustrated retain the rod approximately in its centre        such as to pass between the two mounting tubes (7).    -   FIG. 10 d represents pushing of the rod (6) into the U-shaped        channel of the screw (2) by means of the handle pushing element        (60). The thread (61) located in the proximal portion of the        handle (60) allows exertion of high pushing forces, whereas the        dovetails located in the tubes (7) and (8) reinforce the        assembly in torsion and flexion. For this insertion step of the        rod (6), the retaining element (70) (not illustrated) may be        used perpendicularly in order to counteract the torque        transmitted for pushing, thereby obtaining much better control        of the surgical procedure.    -   FIG. 10 e represents the rod (6) in position at the bottom of        the U shape (25) of the head of the screw (5). The stopper (3)        is not yet engaged in the head of the screw (5) and is        pre-mounted on the locking element holding tube (8).    -   FIG. 10 f represents positioning of the stopper (3) on the head        of the screw (5) by means of the straight handle (70) and the        stopper screwdriver shank (80′).    -   FIG. 10 g represents the step of final fixing of the rod (6) in        the screws (2). The retaining element (70) perpendicularly        provides the counter-torque and retention of the assembly; the        T-shaped handle (60) and the stopper screwdriver shank (80′)        allow exertion of the tightening torque of the stopper (3). As        described above, measurement of the torque required for optimum        tightening may be obtained either by breaking the ring (40), or        by means of the torque-type T-shaped handle (60), or furthermore        by breaking the screwdriver shank (80′).    -   FIG. 11 likewise represents the final tightening step if the        mounting tube (7) is not in position on the screw (2). Indeed        for anatomical and dimensional reasons, the surgeon may have        cause to disassemble the tube during surgery. This eventuality        is rare, but sometimes necessary for proper conduct of surgery.        In this configuration, counter-torque retention of the head of        the screw (5) is provided by the handle (70) advantageously        equipped with a shape complementary to said head of screw (5) as        described above. The torque-type T-handle (60) and the stopper        screwdriver shank (80′) allow exertion of the stopper tightening        torque necessary for a good hold of the implant. In this        configuration, the mounting tube (7) may be used as a        counter-torque perpendicular handle by means of the indentation        (71) (not illustrated).    -   Advantageously, this configuration is used for untightening the        stopper, for removing the implants or for any other surgical        step requiring separation of the connection between the screw        (2)/rod (6).

Advantageously, in order to reduce the number of instruments requiredfor insertion of the implants, the compression and distraction plieronly form a single pair of plier. In the state of the art, these pliersare made up of two articulated arms, with the proximal portions of thesepliers being formed of forks overlapping the rod (6), said same forksexerting the desired compression/distraction forces on the implants.

FIG. 12 represents the compression plier (90). This plier mainlyconsists of two arms (91) and (92) and a joint (93). Each arm (91) and(92) is equipped with a curved end (94) and (95) ending in said forkshape.

Advantageously, the joint (93) is easily removable.

FIG. 13 represents these same arms (91) and (92) used for a distractionmanoeuvre. Advantage is taken of the curved shape of the two curvedproximal ends (94) and (95) so that the latter are able to “roll” oneach other, thereby exerting the distraction force between the screws(2) by compression of both arms (91) and (92).

In the preferred configuration, two curved proximal ends (94) and (95)include notching in their convex portions in order to prevent frontalsliding of the two arms (91) and (92).

Advantageously, as illustrated in FIG. 14, the two curved proximal ends(94) and (95) comprise a means (97) of interconnection in order toprevent lateral sliding of the two arms (91) and (92).

In the preferred configuration, this interconnection consists of a stud(98) arranged in one of the curved proximal ends (94) or (95) and agroove (99) arranged in the other curved proximal end.

FIG. 15 describes a device (100) for performing spinal stabilisationaccording to a second embodiment. In this embodiment, the device (100)comprises two bone anchoring elements (2) interdependently pre-mountedon mounting tubes (7) and two locking elements designed to lock theconnecting rod (6) on the bone anchoring element, said locking elementsbeing pre-mounted on tightening tubes (8). Advantageously, the tubes (7)comprise a pre-mounted handle (60) and a screwdriver (80). Thearrangement of these elements will be described further below, inrelation with FIGS. 20, 21 a and 21 b.

The set of tubes/screwdriver/handles/screw and tubes/locking elementsare arranged in a sealed packaging (120), for sterile and disposablepacking.

The set thus packed forms a bone anchoring kit, making available twobone anchoring elements and two locking elements for performing spinalstabilisation using a connecting rod.

It is of course obvious that provision can be made for bone anchoringkits comprising more than two bone anchoring elements and two lockingelements pre-mounted on tubes as described above without as a resultdeparting from the field of the invention.

FIG. 16 describes a kit of instruments (110) for insertion or removal ofimplants according to a second example of embodiment of the invention.As in the example of embodiment previously described (FIG. 2), the kitof instruments (110) is for disposable use, sterile packed.

In the embodiment illustrated, the kit of instruments (110) comprisesinstruments for preparation of pedicle holes (spatula, tap sensor), inaddition to instruments required for implantation of the pedicle screwsand connecting rods (screwdriver shank 80, plier 900, 950 and handles60, 70). It should be noted that the plier (900, 950) present in the kitof instruments (110) have a dual functionality which will be describedbelow.

The kit of instruments (110) reiterates the set of characteristics forthe kit of instruments (10) previously described.

FIGS. 17 to 19 represent views of a tube (7) and a retaining ring (40)forming the device in FIG. 15. The tube (7) reiterates the set ofcharacteristics of the tube previously described. In the exampleillustrated in FIG. 15 however, the means employed in order to receive apushing element (or T-shaped handle) (60) in addition to a perpendicularretaining element (70) held, in the example previously described, by thering 40, are now directly held by the tube (7).

Hence, in the embodiment described, the distal portion (7 a) of the tube(7) comprises an external face (7 b) provided with the indentation (36)designed to receive the perpendicular retaining element (70) and aninternal face (7 c) provided with the thread (35) to receive the pushingelement (60). In the embodiment described and in the previous example,the indentation is hexagonal in shape.

Advantageously, the distal portion (7 a) of the tube (7) comprises, inthe extension of the indentation (36) an external thread (7 d) capableof interacting with at least one tongue (400) of complementary shapearranged on the internal face (40 a) of the ring (40), thereby allowingfixing of the ring on the distal end of the tube (7). In this example ofembodiment, the sole function of the ring (40) is to maintain the twohalf-shells (30, 31) in relation to one another.

Advantageously, the external thread arranged on each half-shell (30, 31)is comprised of a double screw thread in order to ensure that the threadis identical on each half-shell such that the thread resulting from thejunction of the threads of the two half-shells is continuous.

Advantageously, the ring (40) has an external diameter smaller than thenominal diameter of the indentation (36) when the two half-shells (30,31) are in position in order to form the tube (7). The aim of thisspecific dimensioning of the ring (40) is to allow passage of theperpendicular retaining element (70) for its position at the level ofthe indentation (36).

Advantageously, the distal portion (7 a) comprises a hole (700) arrangedat the level of the indentation (36) in order to allow passage of ascrewdriver shank (80, 80′) when the retaining element (70) is used as asubstitute for the tube (7), as illustrated in FIG. 22. In thisillustrated embodiment, the tube (7) is used as a replacement for theretaining element (70), with the tube thereby functioning as a handleand the retaining element (70) as a replacement for the tube (7).

FIG. 20 illustrates a cross-sectional view along the axis XX-XX of themounting tube/screwdriver/anchoring element assembly illustrated in FIG.15.

As illustrated in FIGS. 20 and 21 a, the screwdriver shank (80) ispre-mounted on the anchoring element (2). More specifically, theproximal end (80 a) of the screwdriver shank (80) is arranged in orderto interact with the screw (2). Advantageously, the assembly comprisesmeans allowing the screwdriver shank (80) to be maintained in the axisof the threaded portion (4) of the anchoring element (2). By way of anon-restrictive example, the means of maintaining the screwdriver shank(80) in the axis of the bone anchoring element comprise lugs (800)arranged on the internal face of the tube (7).

As illustrated in FIGS. 20 and 21 b, the assembly advantageouslycomprises a retaining fin (60′) for maintaining the screwdriver shank 80in a given position in relation to the tube (7) and the screw (2).

The retaining fin (60′), which is T-shaped, is pre-mounted on the distalend of the tube (7). Its bottom part comprises a thread (61′)corresponding to the tap (35) of the distal portion of the tube (7).

Advantageously, the retaining fin (60′) comprises, over its entirelength, a channel through which the screwdriver shank (80) passes.

The retaining fin (60′) is arranged in order to ensure axial retentionof the screwdriver shank (80) in the tube (7) while allowing arotational movement of the shank inside the tube (7) in order to allowimparting of rotation to the threaded portion (4) of the screw (2), withthe head (5) of the screw remaining immobile in relation to the shank.

According to an advantageous embodiment, it is arranged in order to keepthe alignment of the screwdriver shank (80) in the alignment of the boneanchoring element (2).

Owing to preassembly at the factory of the screwdriver shank (80) on thescrew which is also pre-mounted in a tube (7), reduced tolerance isallowed and consequently better retention of the screw according to theflexion forces is ensured.

A preassembly of this kind also has the advantage of allowing on the onehand a saving in surgery time, with the operation of positioning thescrewdriver shank on the bone anchoring element being eliminated and onthe other hand a limitation in the surgical risk, since the duration ofanaesthesia is reduced.

Such a preassembly also has the advantage of avoiding any problems inpairing the screwdriver shank/screw.

In the same manner as in the embodiment illustrated in FIG. 11, the tube(7) can be used as a perpendicular handle and the perpendicular handle(70) as a guide tube of a stopper screwdriver shank (80′) (FIG. 22).

FIGS. 23 a and 23 b represent a compression plier (900) contained in thekit of instruments (110). The compression plier (900), which has a planeof symmetry P, comprises two arms (910), (920) mounted articulated inrelation to each another. In the embodiment described, the arms arearranged crossed in relation to each another.

As for the compression plier described above (FIG. 12), each arm (910,920) has a fork-shaped curved end (930), wherein the fork-shaped ends(930) of each arm are arranged opposite one another in relation to theplane of symmetry in order to be able to overlap the rod (6). The endsof the arms thus arranged form ends of the plier known as compressionends (930).

Advantageously, the opposite ends (940) to the compression ends (930)are arranged in order to allow gripping the rod (6) by moving the arms(910, 920) towards each other. One will subsequently refer to grippingends (940) of the plier (900). In order to facilitate gripping, thegripping ends (940) of each arm (910, 920) comprise two fingers defininga space for receiving the rod (6). Hence, when the arms (910, 920) arein the close position, the rod (6) is retained trapped between thefingers of the gripping ends (940) of each of the arms.

Thus configured, the compression plier (900) allows, by means of theircompression ends (930), exertion of a compression force on the boneanchoring elements, as illustrated in FIG. 23 b and by means of theirgripping ends (940), opposite the compression ends, holding of the rod,as illustrated in FIG. 23 a. This dual functionality makes it possibleto reduce the number of instruments required for insertion of theimplant and therefore reduce the number of instruments to be handledaccordingly.

In order to reduce the force required to effect compression of theimplants, the joint (901) is designed to ensure that the distancebetween the compression ends (930) and the joint (901) is less than thedistance between the gripping ends (940) and the joint (901), with thedistance being considered according to the longitudinal axis of theplier.

FIGS. 24 a and 24 b represent a distraction plier (950) contained in thekit of instruments (100).

In this embodiment, the distraction plier (950), which has a plane ofsymmetry P′, comprises two arms (960), (970) hinged to each other by ajoint (951).

Each end (980) of each arm (960, 970), with a fork-shaped configuration,is arranged in order to overlap a rod (6) as illustrated in FIGS. 24 aand 24 b. Therefore, according to their positioning on the rod (6),depending on whether they are positioned between the two anchoringelements (2) (FIG. 24 b) or on either side of the two anchoring elements(2) (FIG. 24 a), the ends will be able to exert desireddistraction/compression forces on the rod (6). In this case, one willrefer to distraction ends (980) or compression ends (990).

This dual functionality makes it possible to reduce the number ofinstruments required for insertion of the implant and therefore reducethe number of instruments to be handled accordingly.

In order to allow compressions over a wide distance, the joint (951) isdesigned to ensure that the distance between the distraction ends (980)and the joint (951) is less than the distance between the compressionends (990) and the joint (951), with the distance being consideredaccording to the longitudinal axis of the plier.

Thus configured, the distraction plier (950) allows, by means of theircompression ends, exertion of a distraction force on the implants, asillustrated in FIG. 24 b and by means of their gripping ends, exertionof a wide compression force, as illustrated in FIG. 24 a.

FIGS. 25 a to 25 c illustrate the assembly steps of a stopper (3) on thehead (5) of the screw (2) when the mounting tube (7) has been dismantledfrom the screw (2).

Therefore and as illustrated in FIG. 25 a, the tube (8) bearing thestopper (3) is positioned on the head (5) of the screw by sliding thetube (8) along one of the half-shells (30, 31) mounted on the head (5)of the screw. The half-shell (30) thereby allows guiding of the stopper(3) towards the screw head.

Once the tube (8) completely rests in the half-shell (30) (FIG. 25 b),the stopper screwdriver shank (80′) is inserted into the canal of thelocking tube (8) in order to proceed with tightening the stopper (3) onthe rod (6) (not illustrated in the figures but present) and on the head(5) of the screw (FIG. 25 c).

The embodiment illustrated in FIGS. 25 a to 25 c is advantageous in thesense that only a single half-shell of the tube (7) is necessary inorder to allow guiding and positioning of the stopper (3) on the head(5).

The invention is described above by way of an example. It is understoodthat the person skilled in the art is capable of producing differentvariants of embodiment of the invention without departing from theframework of the invention.

1-56. (canceled)
 57. A spinal device for fixing vertebrae via aposterior or posterolateral approach comprising: a bone anchoringelement of a pedicle or vertebral screw type, comprising a proximalportion equipped with an interface for attaching a rod-type orplate-type connecting element and a threaded distal portion, a mountingtube interdependently pre-mounted on the bone anchoring element, saidmounting tube being removable from the bone anchoring element, and asterile sealed packaging of the bone anchoring element and thepre-mounted mounting tube.
 58. The spinal device for fixing vertebraeaccording to claim 57, wherein the mounting tube comprises alongitudinal opening, emerging in the proximal portion of the boneanchoring element for passage of the connecting element.
 59. The spinaldevice for fixing vertebrae according to claim 57, further comprising alocking element, wherein an internal diameter of the mounting tubeallows passage of the locking element of the connecting element on thebone anchoring element.
 60. The spinal device for fixing vertebraeaccording to claim 57, further comprising a locking element, in additionto accessories, wherein an internal diameter of the mounting tube allowspassage of the accessories for positioning of the locking element. 61.The spinal device for fixing vertebrae according to claim 57, furthercomprising an accessory passing through the mounting tube and having oneend pre-mounted on the bone anchoring element.
 62. The spinal device forfixing vertebrae according to claim 61, wherein the mounting tube isprovided with means for retaining the accessory in alignment with thebone anchoring element.
 63. The spinal device for fixing vertebraeaccording to claim 62, wherein the means for retaining comprise lugsarranged on an internal face of the mounting tube.
 64. The spinal devicefor fixing vertebrae according to claim 62, wherein the means forretaining comprise a retaining fin installed on an opposite end to anend bearing the bone anchoring element of the mounting tube.
 65. Thespinal device for fixing vertebrae according to claim 64, wherein theretaining fin is arranged with the mounting tube in order to allow anaxial rotational movement of the accessory inside the mounting tube. 66.The spinal device for fixing vertebrae according to claim 61, whereinthe accessory is a screwdriver shank.
 67. The spinal device for fixingvertebrae according to claim 57, wherein the mounting tube is made ofcomposite, polymer, ferrous or non-ferrous alloy material or acombination thereof.
 68. The spinal device for fixing vertebraeaccording to claim 57, wherein the mounting tube is overmoulded on thebone anchoring element.
 69. The spinal device for fixing vertebraeaccording to claim 57, wherein the mounting tube is made of at least onematerial, with said at least one of material being incompatible with anautoclave sterilization cycle involving a holding phase at 134° C. for18 minutes.
 70. The spinal device for fixing vertebrae according toclaim 57, wherein a distal end of the mounting tube comprises anindentation for positioning a handle-type perpendicular retainingelement.
 71. The spinal device for fixing vertebrae according to claim57, wherein a distal end of the mounting tube comprises a threaded ortapped area.
 72. The spinal device for fixing vertebrae according toclaim 57, wherein the mounting tube consists of two half-shells, whereineach of the half-shells has a proximal end interdependently pre-mountedon the bone anchoring element.
 73. The spinal device for fixingvertebrae according to claim 72, wherein the two half-shells areidentical and arranged facing each other.
 74. The spinal device forfixing vertebrae according to claim 71, wherein distal portions of thetwo half-shells are contiguous.
 75. The spinal device for fixingvertebrae according to claim 74, wherein the two half-shells comprise atthe level of their contiguous portions a mortise and tenon positioningmeans.
 76. The spinal device for fixing vertebrae according to claim 74,wherein the distal portions of the two half-shells are adhesivelybonded, soldered or furthermore clipped.
 77. The spinal device forfixing vertebrae according to claim 72, wherein the two half-shells areretained interdependently with each other at a level of a distal end.78. The Spinal device for fixing vertebrae according to claim 77,wherein the two half-shells are retained with each other at the level oftheir distal end by means of a ring.
 79. The spinal device for fixingvertebrae according to claim 78, wherein the ring comprises at least onebayonet-type shape which interconnects with studs arranged on the twohalf-shells.
 80. The spinal device for fixing vertebrae according toclaim 79, wherein a compression spring is located between the ring andthe two half-shells.
 81. The spinal device for fixing vertebraeaccording to claim 78, wherein the ring comprises at least onetransverse spindle between the ring and the two half-shells.
 82. Thespinal device for fixing vertebrae according to claim 81, wherein thedimensioning of the transverse spindle is defined such as to break undera shear load according to a given torque.
 83. The spinal device forfixing vertebrae according to claim 78, wherein the mounting tube andthe ring are arranged to form a rigid assembly.
 84. The spinal devicefor fixing vertebrae according to claim 72, wherein the two half-shellsare arranged to form a guide tube when retained interdependently witheach other.
 85. The spinal device for fixing vertebrae according toclaim 84, wherein the guide tube formed by the two half-shells has aninternal diameter allowing passage of the locking element of theconnecting element on the bone anchoring element.
 86. The spinal devicefor fixing vertebrae according to claim 84, wherein the guide tubeformed by the two half-shells has an internal diameter allowing passageof accessories ensuring positioning of the locking element.
 87. Thespinal device for fixing vertebrae according to claim 72, wherein thetwo half-shells each have a proximal end arranged to lock intoengagement with the bone anchoring element.
 88. The spinal device forfixing vertebrae according to claim 57, wherein the locking element isinterdependently pre-mounted with a locking element holding tube inorder to form a locking assembly, with the locking element beingremovable from the locking element holding tube.
 89. The spinal devicefor fixing vertebrae according to claim 88, wherein the locking assemblyis sterile packed.
 90. The spinal device for fixing vertebrae accordingto claim 88, wherein the locking assembly is sterile packed in thesealed packaging.
 91. The spinal device for fixing vertebrae accordingto claim 88, wherein the locking element holding tube is of dimensionsthat allow insertion of the locking element holding tube into themounting tube.
 92. The spinal device for fixing vertebrae according toclaim 91, wherein the mounting tube has a tubular internal wall providedwith at least one locating relief, with the locking element holding tubehaving a complementary locating relief of a shape complementary with thelocating relief of the mounting tube.
 93. The spinal device for fixingvertebrae according to claim 88, wherein the locking element holdingtube has a proximal portion provided with a bearing relief, locatedfacing with the interdependence interface of the bone anchoring elementwhen the locking element holding tube is inserted into the mountingtube, in order to rest a connecting element on the interdependenceinterface of the bone anchoring element.
 94. The spinal device forfixing vertebrae according to claim 88, further comprising a pushingelement interacting with the locking element holding tube for insertionof the locking element holding tube into the mounting tube.
 95. Thespinal device for fixing vertebrae according to claim 94, wherein thepushing element comprises a thread or a tap which interacts with athreaded or tapped area of the mounting tube for positioning of theconnecting element.
 96. The spinal device for fixing vertebrae accordingto claim 88, wherein the mounting tube, when the locking element holdingtube is positioned inside the mount tube forms a guide tube.
 97. Thespinal device for fixing vertebrae according to claim 88, wherein themounting tube and the locking element holding tube, when the lockingelement holding tube is positioned inside the mounting tube, forms arigid assembly.
 98. The spinal device for fixing vertebrae according toclaim 88, wherein the locking element holding tube has an internal shapeallowing passage of a screwdriver.
 99. The spinal device for fixingvertebrae according to claim 88, wherein the locking element holdingtube is made of composite, polymer, ferrous or non-ferrous alloymaterial or a combination thereof.
 100. The spinal device for fixingvertebrae according to claim 57, wherein the bone anchoring element, theconnecting element, the mounting tube and the packaging are disposable.101. The spinal device for fixing vertebrae according to claim 57,wherein the bone anchoring element, the connecting element, and themounting tube packed in a sterile manner in at least one sealed package.